| Generic Name |
Aceclofenac BP
|
| Trade/Brand Name |
To be submitted at the time of inclusion.
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| Presentation |
Film Coated Tablet.
Each tablet contains Aceclofenac BP 100 mg.
|
| Indications |
Pain and inflammation in Rheumatoid arthritis, Osteoarthritis and Ankylosing spondylitis. Also indicated for symptomatic treatment of pain and inflammation in Post traumatic pain, Cervical pain and Low back pain.
|
| Dosage & administration |
Adult : 100 mg twice daily.
Children : Not recommended.
Elderly : Not necessary to modify the dose or dose frequency.
|
| CONTRAINDICATIONS |
Aceclofenac should not be administered to patients with active or suspected peptic ulcer or GI bleeding. Aceclofenac is contraindicated in patients with severe heart failure, moderate to severe renal or hepatic impairment. It is contraindicated to patients previously sensitive to Aceclofenac or in whom Aspirin or NSAID precipitate attacks of asthma, acute rhinitis or urticaria or who are hypersensitive to these drugs.
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| SIDE EFFECT |
The majority of side effects observed have been reversible and of a minor nature and include gastrointestinal disorders (dyspepsia, abdominal pain, nausea and diarrhoea) and occasional occurance of dizziness, dermatological complaints including pruritus, rash and abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.
|
| Warnings & Precautions |
Precautions should be taken to patients suffering from gastrointestinal disease and to those with a history of peptic ulceration, cerebro-vascular bleeding, ulcerative colitis, crohn’s disease or coagulation disorders.
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| Drug Interactions |
Like other NSAIDs Aceclofenac may increase plasma concentrations of Lithium and Digoxin. Aceclofenac, like other NSAIDs, may inhibit the activity of Diuretics. Aceclofenac may enhance the activity of Anticoagulants. Caution should be exercised if NSAIDs and Methotrexate are administered within 24 hours of each other, since NSAIDs may increase Methotrexate plasma levels, resulting increase toxicity. Concomitant therapy with Aspirin, other NSAIDs and Steroids may increase frequency of side effects. Other drugs that interact are Cyclosporin and Quinolone.
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| Paediatric Use |
The safety & effectiveness of Aceclofenac have not been established in paediatric patients & adolescents less than 18 years of age.
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| Use in Pregnancy & Lactation |
There is no information on the use of Aceclofenac during pregnancy and the secretion of Aceclofenac to breast milk. The use of Aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the mother outweigh the possible risks to the fetus.
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| Package Quantity |
Box containing 10 X 10 Tablets in blister pack.
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